Coronary Heart Disease Risk in Type 2 Diabetes
CORDIA
A Randomised Control Trial (RCT) to Investigate the Effectiveness of a Selfmanagement Intervention and Personalised Genetic Risk Information to Reduce Risk of Coronary Heart Disease in Patients With Type 2 Diabetes.
2 other identifiers
interventional
211
1 country
10
Brief Summary
The primary objective of the CORDIA study is to use an effective evidence-based self-management intervention (SMI) for type 2 diabetes, with and without a novel test to give a personalised genetic and lifestyle risk of coronary heart disease, to examine their capacity to reduce the risk of coronary heart disease (CHD) and improve diabetes management in primary care patients with type 2 diabetes. The effect of these interventions on clinical, behavioural and psychological outcomes will be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 4, 2016
August 1, 2016
2.9 years
June 28, 2013
August 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Coronary heart disease 10 year risk
Coronary heart disease 10 year risk as assessed using the United Kingdon Prospective Diabetes Study (UKPDS) Risk Calculator
12 months
Secondary Outcomes (3)
Psycho-social impact of the intervention
12 months
Health behaviour impact of the intervention
12 months
Impact of receiving genetic results
6 months
Study Arms (3)
Usual Care
NO INTERVENTIONThe participant's General practitioner (GP) practice and/or practice nurse will provide care as normal for their patient.
Group Self-Management Intervention (SMI)
ACTIVE COMPARATORParticipants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis.
SMI + Risk Results
ACTIVE COMPARATORThe participant will provide a saliva sample for analysis. They will attend an appointment with their nurse to receive personalised results on their combined genetic and lifestyle risk for developing CHD in the next 10 years. They will then be asked to attend the 4 week SMI programme.
Interventions
The SMI will incorporate a discussion to introduce self-management and why it is important, and about problems associated with reducing CHD risk and managing type 2 diabetes. Specific topics addressed will include health behaviours to reduce CHD risk and manage diabetes including diet and exercise, as well as behaviours specific to managing diabetes, including medication adherence and self-care behaviours (e.g. footcare). Sessions are patient-directed and employ a shared decision-making approach, such that participants work with one another and the practice nurse facilitator to identify specific problems that they wish to address, and to identify solutions and approaches to managing their diabetes and CHD risk
Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD.
Eligibility Criteria
You may qualify if:
- Males and females aged 25-70 years diagnosed with type 2 diabetes
- White, Afro-Caribbean or Asian-Indian ethnicity
- Most previous or baseline HbA1c ≥6.5% or 48 mmol/mol
- Fluency in written and spoken English
You may not qualify if:
- Diagnosis of ischemic heart disease, stroke, Transient Ischaemic Attack (TIA) or peripheral vascular disease
- Serious or enduring mental health problems that would prevent the patient from completing the study
- Currently receiving treatment for a life-threatening condition (e.g., cancer) or in the terminal stages of a condition
- Adults who cannot consent for themselves
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City, University of Londonlead
- University College, Londoncollaborator
Study Sites (10)
Addison House Surgery
Harlow, Essex, CM20 1DS, United Kingdom
Church Street Surgery
Ware, Essex, SG12 9EG, United Kingdom
Dolphin House Surgery
Ware, Essex, SG12 9HJ, United Kingdom
Wallace House Surgery
Hertford, Hertfordshire, SG14 1HZ, United Kingdom
Cambridgeshire Community Services NHS Trust
Cambridgeshire, PE27 4LG, United Kingdom
Chesterfield Drive Surgery
Ipswich, IP1 6DW, United Kingdom
Martlesham health Surgery
Ipswich, IP5 3SL, United Kingdom
Dr Taylor and Partners
Woodbridge Suffolk, IP12 1EE, United Kingdom
The Peninsula Practice
Woodbridge Suffolk, IP12 2NN, United Kingdom
Wickham Market Medical Centre
Woodbridge Suffolk, IP13 0SB, United Kingdom
Related Publications (2)
Beaney KE, Ward CE, Bappa DA, McGale N, Davies AK, Hirani SP, Li K, Howard P, Vance DR, Crockard MA, Lamont JV, Newman S, Humphries SE. A 19-SNP coronary heart disease gene score profile in subjects with type 2 diabetes: the coronary heart disease risk in type 2 diabetes (CoRDia study) study baseline characteristics. Cardiovasc Diabetol. 2016 Oct 3;15(1):141. doi: 10.1186/s12933-016-0457-7.
PMID: 27716211DERIVEDDavies AK, McGale N, Humphries SE, Hirani SP, Beaney KE, Bappa DA, McCabe JG, Newman SP. Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial. Trials. 2015 Dec 2;16:547. doi: 10.1186/s13063-015-1073-7.
PMID: 26631181DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stanton P Newman, PhD
City, University of London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 28, 2013
First Posted
July 3, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 4, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share